Method of applying semisolid bacteriostatic pads to urinary catheters

ABSTRACT

Wrapping around the shaft of a body catheter a bacteriostatic pad made of a nonwoven fabric impregnated with a bacteriostatic agent incorporated in a semisolid base to form a protective bacteria barrier around the catheter shaft at its entry into the urinary meatus. The semisolid base holes the bacteriostatic agent in intimate contact with the catheter shaft and the meatus surrounding the catheter shaft to provide an effective bacteriatight seal against entry of bacteria between the shaft and the meatus. Thus, it prevents the migration of bacteria along the catheter shaft into the body.

United States Patent 1,888,349 11/1932 Jacoby inventor Appl. No. Filed Patented Afisignec METHOD OF APPLYING SEMISOLID BACTERIOSTATIC PADS TO URINARY CATHETERS 4 Claims, No Drawings US. Cl 128/349 R,

Int. Cl A6 1m 2 00 Field of Search 128/348-351, 155,171,260, 261; 424/14, 28

References Cited UNITED STATES PATENTS Pn'mary Examiner-Dalton L. Truluck AttarneyW. Saxton Seward ABSTRACT: Wrapping around the shaft of a body catheter a bacteriostatic pad made of a nonwoven fabric impregnated with a bacteriostatic agent incorporated in a semisolid base to form a protective bacteria barrier around the catheter shaft at its entry into the urinary meatus. The semisolid base holes the bacteriostatic agent in intimate contact with the catheter shaft and the meatus surrounding the catheter shaft to provide an effective bacteriatight seal against entry of bacteria between the shaft and the meatus. Thus, it prevents the migration of bacteria along the catheter shaft into the body.

METHOD OF APPLYING SEM ISOLID BACTERIOSTATIC PADS TO URINARY CATHETERS THE PROBLEM During bladder drainage after the catheter is inserted in the meatus, a purulent crusty' exudate forms about the shaft of the catheter immediately distal to and on the external urinary meatus. This exudate is formed from body excretions and is a nesting place for the growth of bacteria which travel along the outside of the catheter shaft into the body and cause infection.

This problem has existed as long as catheters have existed and has been recognized by many authorities in the field.

PRIOR ATTEMPTS TO SOLVE PROBLEM In order to overcome this problem, it has been suggested to cleanse the external meatus once or twice a day withliquid aqueous [l::l,000 or 1:750] benzalkonium chloride solution applied from a syringe or by impregnating the catheter with a bacteriostatic agent. See article by Dr. Robert E. Desautels in Hospital Medicine, Mar. I965, a reprint of which is furnished herewith.

Although this may be a help, infections by virtue of entry of bacteria via this path have continued. One reason for this is believed to be that the benzalkonium chloride solution, being a thin, watery, free-flowing liquid, tends to run off, and evaporate from, the critical body areas, e.g. the external urinary meatus where the exudate deposits, so that contact of the bacteriostatic agent with such areas, and hence the bacteriainhibiting action, is not sustained. Furthermore, there is the obvious disadvantage that the nurse is apt to forget to apply the benzalkonium chloride periodically. Also, there is the inconvenience to the nurse of preparing and handling the liquid benzalkonium chloride by means of a syringe, or even with a surgical gauze sponge. Due to the aforesaid free-flowing characteristics of the solution it tends to run down over the patient and the bed, i.e. it is messy for nurse and patient.

STATEMENT OF THE INVENTION These problems are overcome in accordance with the present invention by applying, as by wrapping, snugly around the shaft of the inserted catheter in intimate contact therewith and with the meatus surrounding it, a self-adhering pad comprising a porous fibrous carrier, preferably a nonwoven fabric, impregnated with a bacteriostatic agent for inhibiting the growth of urinary pathogenic bacteria and incorporated in a semisolid base, preferably a lubricating jelly commonly used for lubricating catheters and other urological instruments, to thereby form an effective bacteria barrier extending from around the catheter shaft to the surrounding meatus to thereby close the space therebetween to bacteria. The semisolid base forms a protective bacteriaproof seal between the catheter shaft and the pad and between the meatus, where the exudate forms, and the pad. In effect, it bridges the space between the shaft and the meatus to fonn a substantially bacteria-free zone. It adheres the pad to the catheter shaft and meatus to maintain for as long as bacteria control is necessary or prescribed, the bacteriostatic agents in contact with the shaft and meatus to thereby maintain the aforesaid barrier and bacteria-free zone for sustained periods of time. Put in another way, the semisolid base fills the space between the catheter and meatus to eliminate possible voids which might provide a portal of entry for bacteria. In fact, it may penetrate slightly into the urethra around the shaft.

The bacteria-free sealing area provided by the pad is relatively large and extends not only a good distance longitudinally along the shaft but also extends a good distance peripherally from the meatus and along the body.

The wrapping of the pad about the catheter shaft and in contact with the meatus squeezes the bacteriostatic jelly into the meatal opening, thereby providing a maximum barrier and sealing effect. It also increases the adherence of the wrap to itself and to the shaft and meatus. The oozing of the jelly from the margins of the wrap increases sealing effect.

It is generally recognized that closed drainage systems are essential to prevent infection. A great deal of work has been done in this area. This work has been directed mainly to closing the internal fluid path from the bladder to the collecting vessel. See my US. Pat. application Ser. No. 793,403 and pages 1210 and 1211 of Vol. 274, No. 21 of the New England Journal of Medicine, issued May 26, 1966.

However, although it has been generally recognized that bacteria may ascend around the lumen of the catheter through the metal opening, nevertheless, no one to my knowledge prior to my invention, has thought of closing the metal opening as I do in my invention to provide a truly closed system when used with a closed drainage system, as described in my aforesaid application in the aforesaid New England Journal of Medicine.

The bacteriostatic jelly-impregnated pad or wrap of the invention is sealed in a vapor-impervious envelope made up of a laminate of an outer paper layer, an intermediate metal foil layer and an inner thermoplastic film liner sealed around its periphery. Accordingly, when a catherization is to be performed it is only necessary to tear open the envelope after the catheter has been inserted and wrap it about the catheter shaft with maximum convenience to the physician or the nurse.

DETAILED DESCRIPTION EXAMPLE A bacteriological pad was prepared and packaged as follows:

Sheets of apertured nonwoven fabric, 4 inches by 4 inches and about 0.010 inch thick, sold by Johnson & Johnson Company under the name Novenette, were uniformly impregnated with a semisolid bacteriostatic lubricating jelly in an amount of three grams per sheet.

The bacteriostatic jelly was one sold by Crown Metro, Inc. Providence, Rhode Island, made by incorporating the bacteriostatic agents, o-Phenylphenol (0.10 percent by weight) and p-tert-Amylphenol (0.02 percent by weight) in a semisolid lubricating, glycerine-based, non-petroleum jelly containing 2.4 percent by weight (based on the bateriostatic jelly) of isopropyl alcohol.

This lubricating jelly base is conventionally sold and used as a lubricant for catheters and other urological instruments. It is a semisolid having a consistency which permits it to stay in place when applied to the body.

The impregnated pads were then folded into a 1 1/2 by 2 inch flat dimension and then packaged in conventional manner in a conventional vapor-impervious flat envelope made up of a laminate of an outer paper layer, an intermediate metal aluminum foil layer and an inner polyethylene film liner which is heat sealed around its periphery to seal the package.

Laboratory tests were performed by taking the common urinary pathogens, Escherichia Coli, Klebsiella-Aerobacter, Pseudomonas Aeruginosa, Proteus species, Staph. aureus and Serratia Marcescens, and innoculating them into culture media placed on plates. The aforesaid bacteriostatic pads were placed over the innoculated media to determine the bacteriostatic activity. It was found to be effective in inhibiting the aforesaid bacteria for three days.

The aforesaid pads have been successfully used clinically by removing the pads from their envelopes at the bed site after insertion of the catheter into the urethra and wrapping them snugly around the catheter shaft where it enters the meatus in intimate contact with such shaft and the surrounding meatus as well as the parts of the body immediately peripheral to the meatus. The pressure applied during the wrapping squeezes the bacteriostatic jelly into the meatus and also out from around the periphery of the wrapped pad. The jelly adhered the pad to the catheter and meatus and the folds of the pad to each other to continuously hold and maintain the jelly and pad in intimate contact with the shaft and the meatus to form a bacteria barrier which is substantially bacteria-free and which closes the space between the catheter and meatus. In effect, the jelly formed a bacteria seal between pad and shaft and between pad and meatus to thereby bridge the space between shaft and meatus.

Any porous and absorbent or adsorbent fibrous carrier, including woven fabrics, can be used in place of .the nonwoven fabric but the latter is by far preferred. Any nonwoven porous fibrous fabric can be used, such as water or acid-laid paper or textile fibers, or a carded web of fibers reinforced by bonding agents which leave the web of fibers porous, or a nonwoven fabric sold under the name Webril by the Kendall Company. Preferably, the fabric is of wet-strength paper. Accordingly, the term fabric", as used herein, includes paper as well as natural and synthetic textile fibers. See U.S. Pat. Nos. 2,702,780, 3,129,81 l 3,093,546 and 3,006,338.

Any bacteriostatic agent effective against the common urinary pathogens can be used in addition to or in place of the phenols, such as hexachlorophene, betadine, polymyxin, neomycin, chlorhexidine and chlorine dioxide and combinations thereof.

Also, any compatible semisolid (e.g. pastes, greases, jellies and ointments) base can be used although nonpetroleum medical lubricating jellies are preferred. Any of the conventional medical lubricating jellies can be used, which are sold for lubricating catheters and other urological instruments, as well as intravenous catheters and wound drainage catheters. These jellies have a relatively high viscosity which permits them to stay in place when applied to the body, i.e. they are not free-running liquids. They tend to adhere to the body surfaces. They have about the same consistency as toothpaste or petroleum jelly but a greater degree of lubricity. Most of these jellies are nonpetroleum jellies, are glycerine and water based and contain a lower alkyl (1 to 3 carbons) alcohol, most commonly isopropyl alcohol or ethyl alcohol, as well as water and a thickening agent such as carboxy methylcellulose, methyl cellulose, other celluloses, etc. They are nonvolatile so that they can stay for long periods without evaporation or drying out. Such lubricating jellies are sold by Badger Laboratories under the name Bur-Sak Lubricating Jelly, by Guardian Chemical Company under the name Lubraseptic, by Day- Baldwin Company under the name Surgilube and by Bur'- roughs Wellcome under the name Lubafax. They are sufficiently flowable to be squeezed from a flexible tube and by squeezing the impregnated pad thereby forcing the jelly to ooze by pressure. 1

They are chemically inert with respect to the bacteriostatic agents.

The bacteriostatic jellies obtained by adding the bacteriostatic agents to these medical jellies have these same properties, i.e. the addition of the bacteriostatic agents does not materially change these properties.

Petroleum-based jellies, pastes and greases are not preferred because they tend to adversely affect many of the conventional catheter materials but where a catheter material is used which is inert to these, e.g. polyethylene intravenous catheters, and various forms of polyurethane indwelling catheters, they can be used providing they are compatible with the bacteriostatic agents and are medically acceptable.

The proportions of bacteriostatic agents to jelly are not particularly important so long as an effective dose of bacteriostatic agent is used, as listed in the 1968 Merck Index, 8th Edition within limits of human toxicity and also keeping in mind that it is uneconomical to use more than is required. The alcohol in the lubricating jelly may be considered as a mild antiseptic. It is also a mild bacteriostatic agent, too mild to be used alone.

A sufficient amount of the bacteriostatic jelly should be used to saturate the nonwoven fabric with an excess so that a layer of the jelly is located on the fabric, e.g. between 0.1 and O .3 g. per square inch of fabric. This insures adequate adhe slon and holding of the pad on the catheter shaft and meatus by the jelly and also a good jelly seal between pad and catheter shaft and between pad and meatus. This also affords maximum bacteriostatic activity.

The vapor and gas impervious sealed package is conventional. See U.S. Pat. No. 3,129,81 l. The intermediate metal foil layer may be aluminum and the inner liner may be of a number of vapor and gas impervious thermoplastic films compatible with the jelly, such as polyethylene, polyvinyl resin or cellulose acetate, which permits the panels of the flat envelope to be heat sealed along their peripheries.

The present invention can be employed not only with urinary catheters but also with any catheters which penetrate body surfaces, such as intravenous catheters or needles, wound drainage tubings, dialyzing tubes, etc.

It is highly advantageous to incorporate in the sterile package for the catheter one or more of the sealed envelopes containing the bacteriostatic pads of the present invention. For example, one or more pads may be included in a prepackaged central supply room overwrap sterile package or kit with the catheter.

Furthermore, the pad may be made relatively thick, e.g. about the same thickness as the aforesaid wrapped pad, and have an aperture therein for receiving the catheter shaft. In this way, the pad can be placed over the catheter by virtue of the aperture before inserting the catheter and then slid into place against the meatus with sufficient compression to achieve a bacterial seal between catheter and pad and between meatus and pad. In this way, the pad lubricates the catheter for insertion purposes and also closes the space between the catheter and meatus.

Although the pad of the invention can be most advantageously used as aforesaid to close this space, nevertheless, it can also be used as a swab or wipe to remove the crusty exudate.

The invention is not intended to be limited to the specificities of the above but only to the following claims and their equivalents.

lclaim:

1. In the management of urethral catheterization to prevent migration of pathogenic bacteria along the catheter shaft into the body, the method which comprises applying around the shaft of the catheter in intimate contact with and covering the portion of the outside of the body immediately surrounding the catheter where it enters the body and in intimate contact with the catheter shaft, a separate flexible porous fibrous pad impregnated with an expressible quantity of a semisolid material containing a bacteriostatic agent, compressing said pad to express a portion of said material and agent onto said shaft and onto said surrounding body portion, whereby said pad and said material and agent close the space between the catheter and the body to form a protective bacteria barrier, and leaving the pad so applied during a substantial time interval while said catheter is in the body.

2. In the management of urethral catheterization according to claim 1, the method in which the material is a semisolid lubricating jelly, and which includes forming a seal between the pad and the body portion and between said pad and said shaft.

3. In the management of urethral catheterization according to claim 2, the method in which the bacteriostatic agent is selected from the group consisting of o-phenylphenol, p-tertamylphenol, hexachlorophene, betadine, polymyxin, neomycin, chlorhexadine and chlorine dioxide.

4. In the management of urethral catheterization according to claim 2, the method which includes wrapping the pad tightly around the catheter shaft. 

1. In the management of urethral catheterization to prevent migration of pathogenic bacteria along the catheter shaft into the body, the method which comprises applying around the shaft of the catheter in intimate contact with and covering the portion of the outside of the body immediately surrounding the catheter where it enters the body and in intimate contact with the catheter shaft, a separate flexible porous fibrous pad impregnated with an expressible quantity of a semisolid material containing a bacteriostatic agent, compressing said pad to express a portion Of said material and agent onto said shaft and onto said surrounding body portion, whereby said pad and said material and agent close the space between the catheter and the body to form a protective bacteria barrier, and leaving the pad so applied during a substantial time interval while said catheter is in the body.
 2. In the management of urethral catheterization according to claim 1, the method in which the material is a semisolid lubricating jelly, and which includes forming a seal between the pad and the body portion and between said pad and said shaft.
 3. In the management of urethral catheterization according to claim 2, the method in which the bacteriostatic agent is selected from the group consisting of o-phenylphenol, p-tert-amylphenol, hexachlorophene, betadine, polymyxin, neomycin, chlorhexadine and chlorine dioxide.
 4. In the management of urethral catheterization according to claim 2, the method which includes wrapping the pad tightly around the catheter shaft. 